| CTRI Number |
CTRI/2025/02/080976 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of Mind Sound Resonance Technique on Blood Sugar Levels in Patients with Type 2 Diabetes |
|
Scientific Title of Study
|
Effect of Mind Sound Resonance Technique(MSRT) on glycemic control in patients with type 2 diabetes mellitus. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sindhu V |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of yoga, Second floor, government yoga and naturopathy medical college, PG block, Arumbakkam, Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9360671550 |
| Fax |
|
| Email |
sindhuveeramuthuveeramuthu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Mooventhan |
| Designation |
Assistant Medical Officer cum Lecture Grade 2 |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of Research, Second floor, government yoga and naturopathy medical college, PG block, Arumbakkam, Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sindhu V |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Department of yoga, Second floor, government yoga and naturopathy medical college, PG block, Arumbakkam, Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
9360671550 |
| Fax |
|
| Email |
sindhuveeramuthuveeramuthu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy Medical College and Hospital, Arumbakkam, Chennai - 600106 |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Government Yoga and Naturopathy Medical College and Hospital,
Arumbakkam, Chennai - 600 106 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sindhu V |
Government Yoga and Naturopathy Medical College and Hospital |
Department of yoga, Second floor, government yoga and naturopathy medical college, PG block, Arumbakkam, Chennai-106
Chennai
TAMIL NADU |
9360671550
sindhuveeramuthuveeramuthu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy Medical College and Hospital, Chennai institutional ethical committee |
Approved |
| Government Yoga and Naturopathy Medical College and Hospital, Chennai institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E11||Type 2 diabetes mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Mind Sound Resonance Technique(MSRT) |
patients will be rested in the supine position and the Relaxation technique MSRT will be directed 30 minutes, 3 days a week for two weeks. |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients are on oral antidiabetic medications
patients who are willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Patients who are on insulin injection therapy
Patients who are not willing to participate in the study
Women during pregnancy and lactation
Patients with difficulty lying in the same position for more than 30 minutes.
Psychiatric comorbidities:(Eg: Psychosis)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Fasting blood glucose and Post Prandial blood glucose |
The Mind Sound Resonance Technique will be practiced for 30 minutes a day, 5 days a week, over 2 weeks. Fasting Blood Glucose and Postprandial Blood Glucose levels will be assessed before the study begins (baseline) and after the study is completed (end of 2 weeks) using venous blood samples (5ml) collected in a standard laboratory setting |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The DASS-21 comprises 21 questions divided into three subscales that evaluate symptoms of stress, anxiety, & depression. Respondents are asked to rate the extent to which they agree with the symptoms on a scale of 0 (did not apply to me at all) to 3 (used to me very much or most of the time) |
DASS-21 assessments will be conducted at baseline, before the start of the intervention, & after the study is completed (end of 2 weeks) |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The Mind Sound Resonance Technique(MSRT)a yoga-based relaxation technique uses mantras to create resonance which results in deep relaxation for the body and mind. 50 participants will be enrolled for the pre-test and post-test study design. MSRT directed 30 mins, 5 days for 2 weeks. The primary outcome of the study will be fasting blood glucose and postprandial blood glucose. The secondary outcome of the study is depression, anxiety, and stress scale (DASS-21). Both primary and secondary outcomes will be assessed before and after the intervention of MSRT session. |